Earnings Labs

ClearPoint Neuro, Inc. (CLPT)

Q1 2018 Earnings Call· Tue, May 15, 2018

$11.02

-1.69%

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Transcript

Operator

Operator

Greetings, and welcome to the MRI Interventions' 2018 First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded. The comments made on this call may include statements that are forward-looking within the meaning of Securities Laws. These forward-looking statements may include without limitation statements related to anticipated industry trends, the Company's plans, prospects, and strategies both preliminary and projected and management's expectations, beliefs, estimates, or projections regarding future results of operations. Actual results or trends could differ materially. The Company undertakes no obligation to revise forward-looking statements for new information or future events. For more information, please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2017, and the Company's Quarterly Report on Form 10-Q for the three ended March 31, 2018 both of which have been filed with the Securities and Exchange Commission. All the Company's filings may be obtained from the SEC or the Company's website at www.mriinterventions.com. It is now my pleasure to introduce your host Joe Burnett, CEO.

Joseph M. Burnett

Analyst

Thank you Roya and good afternoon everyone. Thanks for joining us for the first quarter 2018 earnings call. With me for today's call is Hal Hurwitz, our CFO. It has been an exciting few months at MRI Interventions including the number of structural and strategic changes designed to expand our future growth opportunities, earn MRI a greater share of revenues from the procedures, our ClearPoint Neuro Navigation System guides and open new opportunities to better leverage our world class team. I am going to briefly turn the call over to Hal to summarize the financial results released earlier today, then I will come back on the line to discuss a few aspects of the quarter and our progress on the four key strategic pillars we announced on our last conference call including the concurrent press release about our new strategic agreement with Voyager. After that we will open up the call for Q&A. Hal.

Harold A. Hurwitz

Analyst

Thank you Joe. For the first quarter ended March 31, 2018 total revenues were $1.6 million compared with $1.6 million for the fourth quarter and $2 million for the same period in 2017. Breaking that down a bit to the underlying product areas, in functional neurology product sales decreased 11% to $1.1 million compared with $1.3 million for the same period in 2017. We completed 160 ClearPoint procedures in the first quarter 2018, level to the preceding quarter and up 11% year-over-year. The difference in revenue largely reflected the mix between single kit and double kit cases and some stocking orders from larger sites in the prior year first quarter. Capital equipment revenue was $263,000 for the first quarter down 23% from $344,000 for the same period in the prior year. Capital equipment fluctuation quarter-to-quarter, we have seen a delay on two system sales related to uncertainty about laser ablation probs. Biologic and drug delivery revenue was $211,000 down 43% year-over-year due to two large orders placed in the first quarter of 2017 that totaled $305,000 versus $74,000 in the current year's first quarter. The company has altered its business practices to encourage customers to take delivery in smaller quantities against open purchase orders rather than bulk purchases in single quarters in an effort to smooth this portion of our revenue and better reflect case utilization in our drug delivery partnerships. Gross margin for the 2018 first quarter was 64% compared to gross margin of 63% for the same period in 2017. The increase in gross margin primarily reflected a favorable mix of products sold. Research and development costs were $546,000 during the 2018 first quarter compared to $558,000 during the same period in 2017. Sales and marketing expenses declined to $962,000 for the 2018 first quarter compared to $1.1 million for the same period in 2017, a decrease of 10%. General and administrative expenses were also down at $953,000 for the first quarter 2018 compared with $984,000 for the first quarter of 2017. Our loss from operations for the 2018 first quarter was $1.4 million up only about 5% year-over-year. Turning briefly to the balance sheet, during the 2018 first quarter cash used in operating activities was $2 million as compared to $1.3 million in the fourth quarter. This increase in burn over the preceding quarter was due to annual bonus payments and one time payments primarily related to personnel. With that I will now turn the call back to Joe.

Joseph M. Burnett

Analyst

Thanks Hal. As you can see the first quarter represented the reset for MRIC as we redefined our growth strategies and set baselines for accountability going forward. As many of you recall on our last report I introduced a reorganization of our corporate strategy and vision to center around four priorities over the next five years. Those were number one, focusing on new efforts to grow our core functional neurosurgery business for deep brain stimulation, laser ablation, and tumor biopsy; number two, leveraging our leadership in live image guidance for precision delivery of biologics and drugs to key and often deep structures of the brain; number three, launching our own new therapy products starting with our precision guided neuro aspiration therapy device in collaboration with the Mayo Clinic; and number four, scaling our business model to both expand globally and better monetize our established sales channel to distribute additional products and services. We believe these four pillars expand our addressable market to more than $1 billion of total opportunity. Our ClearPoint System remains at the center of our platform as the hub enabling surgeons and hospitals to perform different types of procedures relying on ClearPoint accuracy for guidance. These indications including deep brain stimulation, tumor biopsy, laser ablation, and guided aspiration will make up the spokes of the hub and spoke model each relying on different disposable devices, software, and workflows for the most precise and efficient approach possible. We expect that disposable devices will continue to make up more than 80% of our overall revenue staying true to our razor razorblade model. We will also stick to our strengths and focus our commercial efforts today in neurosurgery. I have now taken on direct leadership of our sales and marketing teams to ensure our commercial efforts have the clear and…

Operator

Operator

[Operator Instructions]. Thank you. Our first question comes from the line of Kris Tuttle with SoundView Technology Group. Please proceed.

Kris Tuttle

Analyst

Hey guys, thanks for taking my question. I just got a couple right off the back, could you provide some more color on what the timing of the Voyager shipments are going to be, congratulations on the agreement, it is terrific and just curious to know is that Q2, Q3, Q4 are you going to do some sort of radical revenue recognition on that?

Joseph M. Burnett

Analyst

Hey Kris, thanks for the question. There's a few different elements of the agreement itself that are going to have different timing involved. So again we will continue to supply our current technology as part of the Phase 2 and Phase 3 trials to Voyager. Based on the Voyager communications they expect to start enrolling Phase 2 patients here in the second half of the year and then continuing to a full ramp in 2019 and similar timelines for the Q3 study as well. So shipments for that particular portion of the agreement will commence a little bit later this year. There's other elements to the agreement that without going into too much detail that we're excited about number one is that instead of only playing a role with our technology in some of these cases for Voyager, our clinical specialists will be trained on the Voyager technology and we will actually be providing case support for their technology as well. And that will be sort of an exchange for services and training and capacity and things like that. So, that's another element where we will start getting some revenue almost immediately relative to that portion of the agreement as we train up our sales team to be able to provide some of that support. Some of the other elements of the agreement focus around co-development of different opportunities so, those things depend on the timing and the priorities after our initial kick off sessions for a few of those agreements. So again with -- we can't go into too much detail or too much sort of focus on the timing. However, we're very excited to be able to do a number of different aspects whether it's software, whether it's hardware, whether it's custom cannulas for a number of different indications as well. So those will kind of rollout based on the priority that Voyager needs in their mutual pipeline.

Kris Tuttle

Analyst

Okay, okay thanks. Just one additional question and then I will turn it over, just regarding gross margin you talked about laser ablation dipping a little which might contribute to some gross margin increase over the next couple quarters, is that something we could expect or our new products like the aspiration device, things like that pull that back down?

Joseph M. Burnett

Analyst

You know on the gross margin side I was focused a little bit more on the overall per procedure profitability of the case and less so on gross margin when I made that comment before. So in a typical laser ablation case we typically sell only one smart frame kit at that given ASP. However, we have the cost infrastructure of a person in the room travel to the site, all the logistics around it as well. As you compare that to a bilateral deep brain stimulation where we're selling two kits in the same procedure significantly less profitable overall. However, in many cases the kit themselves is the same so the overall gross margin shouldn't be impacted too much. And I think Hal maybe you can make a couple comments there.

Harold A. Hurwitz

Analyst

Yeah, and I think as far as new products go, it fully ramps up so for whatever modest margin might be represented by first units I wouldn't look for it to have that dramatic an impact on the total.

Kris Tuttle

Analyst

Okay and actually just one more tech question that I don't know if you can help with but do you have any more insight on when the shares might get up listed or listed on regular exchange?

Joseph M. Burnett

Analyst

Yeah, at this point we don't have any update on that side or that part of our strategy. So we're continuing to just build our business in the best possible way that we can. I think the Voyager deal we announced today is certainly a positive to that effect and supports us in a number of different ways both top line and bottom line. So we're just going to continue to focus on execution at this point and bounce back with a strong Q2.

Kris Tuttle

Analyst

Okay, terrific, thanks a lot guys.

Operator

Operator

Thank you. [Operator Instructions]. Our next question comes from the line of Larry Haimovitch with HMTC. Please proceed.

Larry Haimovitch

Analyst · HMTC. Please proceed.

Good afternoon Joe, good afternoon Hal.

Joseph M. Burnett

Analyst · HMTC. Please proceed.

Hi Larry.

Larry Haimovitch

Analyst · HMTC. Please proceed.

So my question is to Joe, what was the thing in the quarter that you particularly were most pleased with and what in the quarter would you say was the biggest disappointment or shortfall in your mind?

Harold A. Hurwitz

Analyst · HMTC. Please proceed.

In the quarter it's Hal, I will start with the negative and end with the positive. I think the awareness that we've talked about in the past of our reliance on other therapies having an impact on us that you know it's not necessarily in our control but the problem solving that we need to do on occasions. And I think we saw that not necessarily with the cases that were impacted, with the concern around laser ablation. However, with the two capital deals that were sort of hung up as a result of it one of which we were pretty sure was going to be closing in Q1. So I think that that was kind of the negative side of things that it would have been excited to get that system in, get eval started and go in with first initial cases. On the positive side I think the way that we were able to respond, I think as leaders our role is to problem solve and not make excuses but rather find new ways to handle things. And I think the speed in which we put together a very mutually attractive agreement with Voyager to help fill some of the gaps that we would see in laser ablation here in 2018 I think is a testament certainly not just to me but to the entire team that really worked tirelessly to get this agreement done and do the proper diligence along the way. So I think ending on a very positive note today was an exciting step for us.

Larry Haimovitch

Analyst · HMTC. Please proceed.

And Joe, how long did it take from when you first started negotiating with Voyager to get this agreement put together?

Joseph M. Burnett

Analyst · HMTC. Please proceed.

You know it is hard to say. I think we've always had -- we continue to have a partnership with Voyager, we always had a relationship. I would say in the past six weeks or so I think we really made an effort to outline what are the priorities and the ways that we want to work together. And moving in as they're preparing to begin their Phase 2 and Phase 3, how can we support and make their procedures more successful. And I think this clinical support side of things is exciting, it saves the company like Voyager from having to spend a good amount of money to build a clinical sales team to support the larger clinical trial and it gives us some operating leverage for the same people that are, very talented and in the room anyway so why can't we help along the way for a small fee.

Larry Haimovitch

Analyst · HMTC. Please proceed.

Okay, and then my final question is you mentioned you are taking more ownership for the sales and marketing side of the business, has that entailed any change in personnel changing or getting -- letting people go and sales management or marketing management or whatever?

Joseph M. Burnett

Analyst · HMTC. Please proceed.

At this point we've simply been refocusing those resources on some of our key projects. Going into January of 2018 we realized that there are a couple of key and high priority sales tools that we simply don't have. So rather than focusing our time and energy and dollars for that matter really on sales management, we have got four very talented territory managers out there that know their business, something I was going to get close to anyway as my role in a small company as the CEO. So really we've been focusing some of the energies of different employees and different roles to really deliver those tools so that we can see the benefit of those in the second half. And as part of the earning script the tips and tricks and efficient workflows is a perfect example of that. Another one is our pro forma analysis that we can sort of redesign and revise the economic benefits using our technology in different hospital settings and different indications. And then there's other marketing tools as well on biopsy that we're focused on rolling out here in preparation of the second half.

Larry Haimovitch

Analyst · HMTC. Please proceed.

Okay, great. Thank you Joe.

Operator

Operator

Thank you. We've reached the end of our Q&A session. I would like to hand the floor back over to management for closing remarks.

Joseph M. Burnett

Analyst

Thank you everyone for joining us today. I hope you can clearly see our enthusiasm for the opportunities ahead as well as our confidence in our ability to grow ClearPoint procedures, increase our installed base, become the leader in biologics and drug delivery to the brain, launch new to world guided therapy or aspiration devices, and achieve progress toward global scale and profitability. As I've said before we are fully committed to becoming an essential part of any modern neurosurgery suite and have a talented team in place with the clear purpose to make it happen. In addition to continuing to report our progress and key milestones we will be attending several upcoming investor events including the LD Micro-Cap Conference in early June. If you have interest in meeting in person at this or another event in the future please contact Matt Kreps at Darrow Associates our investor relations firm using the contact information on our press releases. They will work to ensure you are added to our meeting rosters at these or other upcoming events. Thank you very much and have a good evening.

Operator

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.